Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK

医学 随机对照试验 物理疗法 意向治疗分析 绷带 手腕 外科
作者
Daniel C. Perry,Juul Achten,Ruth Knight,Duncan Appelbe,Susan Dutton,Melina Dritsaki,James Mason,Damian Roland,Shrouk Messahel,James Widnall,Matthew Costa,Raghib Ahmad,Anastasia E. Alcock,Andrew Appelboam,Lisa Armour,Jane Bayreuther,Rhys Beynon,Charlotte Brown,Emily Cadman,Nadine Darlow,Tessa Davis,Phoebe Gibson,Colin Gilhooley,Sylvester Gomes,C. M. Gough,David Hartin,Stuart Hartshorn,Temem Hussan,Nidhi Jain,Emma Jenkinson,Graham R. Johnson,Lisa Kehler,Matthew C. Long,Mark D Lyttle,Shahab Manouchehri,Christopher McKie,David Metcalfe,Louise Morgans,Niall Mullen,Alex Novak,Catherine Nunn,K. P. OʼHagan,A. J. Paul,Jennifer Preston,Shammi Ramlakhan,Aarani Somaskanthan,Yulin Tan,Manish Thakker,Krishna C. Vemulapalli,J. W. N. Weekes,Daniel Westacott,Shawn Wilson,Darryl Wood,Louise Conner,Nicolas Nicolaou,Fergal Monsell
出处
期刊:The Lancet [Elsevier]
卷期号:400 (10345): 39-47 被引量:22
标识
DOI:10.1016/s0140-6736(22)01015-7
摘要

The most common fractures in children are torus (buckle) fractures of the wrist. Controversy exists over treatment, which ranges from splint immobilisation and discharge to cast immobilisation, follow-up, and repeat imaging. This study compared pain and function in affected children offered a soft bandage and immediate discharge with those receiving rigid immobilisation and follow-up as per treating centre protocol.In this randomised controlled equivalence trial we included 965 children (aged 4-15 years) with a distal radius torus fracture from 23 hospitals in the UK. Children were randomly allocated in a 1:1 ratio to the offer of bandage group or rigid immobilisation group using bespoke web-based randomisation software. Treating clinicians, participants, and their families could not be masked to treatment allocation. Exclusion criteria included multiple injuries, diagnosis at more than 36 h after injury, and inability to complete follow-up. The primary outcome was pain at 3-days post-randomisation measured using Wong-Baker FACES Pain Rating Scale. We performed a modified intention-to-treat and per protocol analysis. The trial was registered with ISRCTN registry, ISRCTN13955395.Between Jan 16, 2019, and July 13, 2020, 965 children were randomly allocated to a group, 489 to the offer of a bandage group and 476 to the rigid immobilisation group, 379 (39%) were girls and 586 (61%) were boys. Primary outcome data was collected for 908 (94%) of participants, all of whom were included in the modified intention-to-treat analysis. Pain was equivalent at 3 days with 3·21 points (SD 2·08) in the offer of bandage group versus 3·14 points (2·11) in the rigid immobilisation group. With reference to a prespecified equivalence margin of 1·0, the adjusted difference in the intention-to-treat population was -0·10 (95% CI -0·37 to 0·17) and-0·06 (95% CI -0·34 to 0·21) in the per-protocol population.This trial found equivalence in pain at 3 days in children with a torus fracture of the distal radius assigned to the offer of a bandage group or the rigid immobilisation group, with no between-group differences in pain or function during the 6 weeks of follow-up.UK National Institute for Health and Care Research.
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